1. Safety evaluation of the food enzyme maltogenic amylase from a genetically modified Bacillus subtilis (strain NZYM-SM)
- Author
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EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF), Silano, Vittorio, Bolognesi, Claudia, Castle, Laurence, Chipman, Kevin, Cravedi, Jean-Pierre, Fowler, Paul, Franz, Roland, Grob, Konrad, Gürtler, Rainer, Husøy, Trine, Kärenlampi, Sirpa, Mennes, Wim, Milana, Maria Rosaria, Pfaff, Karla, Riviere, Gilles, Srinivasan, Jannavi, Tavares Poças, Maria de Fátima, Tlustos, Christina, Wölfle, Detlef, Zorn, Holger, Chesson, Andrew, Glandorf, Boet, Herman, Lieve, Jany, Klaus‐Dieter, Marcon, Francesca, Penninks, André, Smith, Andrew, van Loveren, Henk, Želježic, Davor, Aguilera‐Gómez, Margarita, Andryszkiewicz, Magdalena, Arcella, Davide, Kovalkovičová, Natália, Liu, Yi, Engel, Karl‐Heinz, European Food Safety Authority (EFSA), ToxAlim (ToxAlim), Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Institut National Polytechnique (Toulouse) (Toulouse INP), Université Fédérale Toulouse Midi-Pyrénées-Ecole Nationale Vétérinaire de Toulouse (ENVT), Institut National Polytechnique (Toulouse) (Toulouse INP), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Ecole d'Ingénieurs de Purpan (INPT - EI Purpan), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Institut National de la Recherche Agronomique (INRA), and Veritati - Repositório Institucional da Universidade Católica Portuguesa
- Subjects
enzyme alimentaire ,4‐α‐maltohydrolase ,Ingénierie des aliments ,Plant Science ,Bacillus subtilis ,Gene mutation ,[SDV.IDA]Life Sciences [q-bio]/Food engineering ,Glucan 1 ,TX341-641 ,Food science ,Amylase ,4-α-maltohydrolase ,2. Zero hunger ,chemistry.chemical_classification ,Genetically modified microorganism ,biology ,04 agricultural and veterinary sciences ,040401 food science ,Genetically modified organism ,sécurité alimentaire ,food enzyme ,glucan 1 ,4-alpha-maltohydroiase ,maltogenic amylase ,genetically modified microorganism ,Toxicity ,Alimentation et Nutrition ,EC 3.2.1.133 ,amylase ,No-observed-adverse-effect level ,glucane ,Veterinary (miscellaneous) ,TP1-1185 ,Microbiology ,0404 agricultural biotechnology ,Maltogenic amylase ,Food and Nutrition ,Food engineering ,Food enzyme ,business.industry ,Nutrition. Foods and food supply ,Chemical technology ,Food safety ,biology.organism_classification ,Enzyme ,chemistry ,biology.protein ,Animal Science and Zoology ,Parasitology ,business ,[SDV.AEN]Life Sciences [q-bio]/Food and Nutrition ,Food Science - Abstract
International audience; The food enzyme considered is a maltogenic amylase (glucan 1,4-beta-maltohydrolase; EC 3.2.1.133) produced with the genetically modified Bacillus subtilis strain NZYM-SM by Novozymes A/S. The food enzyme contains neither the production organism nor recombinant DNA. The maltogenic amylase is intended for use in baking processes and starch processing for glucose syrups production. Based on the maximum use levels recommended for the food processes and individual consumption data from the EFSA Comprehensive European Food Consumption Database, dietary exposure to the food enzyme-Total Organic Solids (TOS) was estimated to be up to 0.168 mg T'OS/kg body weight (bw) per day in European populations. The food enzyme did not induce gene mutations in bacteria or chromosomal aberrations in human lymphocytes. The subchronic toxicity was assessed by means of a repeated dose 90-day oral toxicity study in rodents. A no observed adverse effect level (NOAEL) was derived (320 mg TOS/kg bw per day), which, compared with the dietary exposure, results in a sufficiently high margin of exposure. The allergenicity was evaluated by searching for similarity of the amino acid sequence to those of known allergens. Three matches to occupational respiratory allergens were found, however, the Panel considered that there are no indications for food allergic reactions to the food enzyme. Based on the genetic modifications performed, the manufacturing process, the compositional and biochemical data provided, the dietary exposure assessment, the findings in the toxicological studies and allergenicity assessment, the Panel concluded that the food enzyme maltogenic amylase from Bacillus subtilis strain NZYM-SM does not give rise to safety concerns under the intended conditions of use.
- Published
- 2018